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Drug Resistant EpilepsyPhase 2/3EKEDRENCT05670847

Exogenous Ketone Esters for Drug Resistant Epilepsy

A Phase 2/3 study testing Exogenous ketone ester in people with Drug Resistant Epilepsy, run by Sohag University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy Read more about this study

Who is it for?
Ages 1 year to 16 years
Conditions the study is for
Drug Resistant Epilepsy
What is being tested?
Exogenous ketone ester
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
10 Jan 2023to 1 Jul 2025
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Drug-resistant epilepsy
  • Seizure frequency ≥ 7 per week

Who cannot join

  • Failure to obtain informed consent
  • Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications
  • Severe disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems
  • Hypo-/hyperglycemia
  • Metabolic acidosis
  • Ketosis (βHB > 2 mmol/L)
Show all 17Show fewer
  • GIT disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease
  • Malnutrition/obesity
  • Limitations to oral feeding (e.g., severe gastroesophageal reflux)
  • Inborn errors of metabolism
  • Chromosomal disorders
  • Surgically-remediable epilepsy
  • Allergies or any other contraindication to ketone supplements
  • Inapplicable recording of seizures
  • Incompliance to anti-seizure medications and/or irregular follow-up
  • Recent propofol therapy
  • Intake of carbonic-anhydrase inhibitors

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elsayed M Abdelkreem, MD, PhD contact

01114232126

d.elsayedmohammed@med.sohag.edu.eg

Egypt1 site, 1 recruiting

  • Department of Pediatrics at Sohag University Hospital

    Sohag, 82524

    Abdelrahim A Sadek, MD, PhD, abdoneurology@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy

This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy

Read the detailed description

Epilepsy is a common neurological disorder among children with significant neurobiological, cognitive, psychological, and social consequences. Seizures can usually be controlled by anti-seizure medications (ASMs) in up to two-thirds of children with epilepsy. However, this leaves a significant part of epileptic children whose seizures are not controlled by pharmacotherapy. Currently, available alternatives for drug-resistant epilepsy (DRE) include surgery, vagus nerve stimulation, and ketogenic diet (KD).

KD has been classically used for treating children with DRE. However, KD requires strict dietary restriction, which may not be applicable or acceptable for many patients, and is associated with several adverse effects, commonly including gastrointestinal (e.g., constipation, nausea, vomiting), cardiovascular (e.g., dyslipidemia), renal/genitourinary (e.g., renal calculi), and growth problems. Exogenous ketone esters (EKE) could be a more convenient and superior alternative to KD for children with DRE.

Being tested
Exogenous ketone ester
Keywords
Drug resistant epilepsy, Exogenous ketone esters, Children
Medical subject headings
Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exogenous ketone esterDrug

    500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days

Study groups in NCT05670847
Study groupRoleWhat they receive
Study groupExperimentalChildren receiving exogenous ketone esters + standard of care
Receives: Drug: Exogenous ketone ester
Control groupNo interventionChildren receiving only standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ≥ 50% reduction in seizure frequency

    Proportion of patients achieving ≥ 50% reduction in seizure frequency

    Measured: From 28-days observation (baseline) phase to 28-days intervention phase

Secondary outcomes (11)

  1. Proportion of incompliance to exogenous ketone ester therapy

    Proportion of doses of exogenous ketone esters which were not administered by patients (as recorded by parents of included children)

    Measured: 28-days intervention phase

  2. Proportion of incompliance to anti-seizure medications (ASMs)

    Proportion of doses of anti-seizure medications (ASMs) which were not administered by children (as recorded by parents of included children)

    Measured: From 28-days observation (baseline) phase to 28-days intervention phase

  3. Change in seizure severity assessed by National Hospital Seizure Severity Scale (NHS3)

    Change in seizure severity assessed by National Hospital Seizure Severity Scale (NHS3)

    Measured: From 28-days observation (baseline) phase to 28-days intervention phase

  4. Change in seizure frequency

    Change in the number of seizures (as recorded by parents of included children)

    Measured: From 28-days observation (baseline) phase to 28-days intervention phase

  5. Change in frequency of status epilepticus

    Change in the number of episodes of status epilepticus (evaluated from patient's medical records)

    Measured: From 28-days observation (baseline) phase to 28-days intervention phase

  6. Change in occurrence of possible adverse effects

    Change in occurrence of possible adverse effects

    Measured: From 28-days observation (baseline) phase to 28-days intervention phase

  7. Change in cognitive domains

    Change in attention, alertness, and memmory, each rated by parents of included children at the end of 28-days intervention phase as no change, improvement, or regression in comparison with the preceding 28-days observation phase

    Measured: From 28-days observation (baseline) phase to 28-days intervention phase

  8. Change in blood βHB

    Change in blood level of beta-hydroxybutyrate

    Measured: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints

  9. Change in blood glucose

    Change in blood level of glucose

    Measured: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints

  10. Change in blood pH

    Change in blood level of pH

    Measured: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints

  11. Change in EEG score

    Change in EEG score according to the scale developed by Walker \& Said (2014), which includes items related to encephalopathy, interictal epileptic discharge, and seizure presence

    Measured: From baseline to 28 days study timepoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2023
  2. Study start10 Jan 2023
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible children will be randomized into two equal-sized groups. Study group: will receive exogenous ketone esters plus standard of care. Control group: will receive only standard of care.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05670847
Sponsor's protocol ID
Soh-Med-22-12-45
Acronym
EKEDRE
Status last verified
Nov 2024
First submitted
18 Dec 2022
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unidentified individual participant data (IPD) underlying study results will be available upon reasonable request

Publications

  • Carson RP, Herber DL, Pan Z, Phibbs F, Key AP, Gouelle A, Ergish P, Armour EA, Patel S, Duis J. Nutritional Formulation for Patients with Angelman Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study of Exogenous Ketones. J Nutr. 2021 Dec 3;151(12):3628-3636. doi: 10.1093/jn/nxab284.

    PubMed 34510212

  • Clarke K, Tchabanenko K, Pawlosky R, Carter E, Todd King M, Musa-Veloso K, Ho M, Roberts A, Robertson J, Vanitallie TB, Veech RL. Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. Regul Toxicol Pharmacol. 2012 Aug;63(3):401-8. doi: 10.1016/j.yrtph.2012.04.008. Epub 2012 May 3.

    PubMed 22561291

  • Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.

    PubMed 29163194

  • Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27.

    PubMed 27475046

  • Gilbert DL, Pyzik PL, Freeman JM. The ketogenic diet: seizure control correlates better with serum beta-hydroxybutyrate than with urine ketones. J Child Neurol. 2000 Dec;15(12):787-90. doi: 10.1177/088307380001501203.

    PubMed 11198492

  • Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.

    PubMed 19889013

  • Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.

    PubMed 28276062

  • Walker I, Said RR. Predictors of Ketogenic Diet Efficacy in Children Based on the Electroencephalogram (EEG). J Child Neurol. 2015 Sep;30(10):1270-4. doi: 10.1177/0883073814556888. Epub 2014 Nov 20.

    PubMed 25414234

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Exogenous ketone ester in people with Drug Resistant Epilepsy, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elsayed M Abdelkreem, MD, PhD (01114232126, d.elsayedmohammed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

≥ 50% reduction in seizure frequency (time frame: From 28-days observation (baseline) phase to 28-days intervention phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05670847, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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